FDA reports that nicotine-like substances in vapes sold in the US may be more potent than actual nicotine.
The U.S. Food and Drug Administration (FDA) and independent experts claim that nicotine alternatives used in vapes being introduced in the U.S. and internationally, including 6-methyl nicotine, may be more strong and addictive than nicotine itself, albeit the scientific proof is still lacking.
The extremely addictive molecule traditional nicotine is the focus of tobacco and vaping legislation in the United States; however, the synthetic chemicals, which share a similar molecular structure with nicotine, are exempt from these laws.
This means that producers do not need to apply for FDA authorization, which may be expensive, time-consuming, and frequently ineffective, in order to sell vapes that include synthetic nicotine analogues like 6-methyl nicotine in the US.
Large tobacco companies like British American Tobacco and Altria Group have already seen a significant decline in U.S. sales due to the proliferation of disposable vapes that include traditional nicotine and are being marketed illegally and without FDA approval.
A copy of the letter that Altria, the company that makes Marlboro cigarettes in the US, sent to the FDA on May 9th, mentioned the growing usage of 6-methyl nicotine in vapes and other smoking alternatives.
It cautioned that the chemicals presented a “new threat” to industry regulation and encouraged the agency to assess the compounds and determine what control it had over them.
If allowed to spread, the introduction and development of substances meant to mimic the effects of nicotine could pose unknown risks to American consumers and jeopardise the FDA’s authority.
It mentioned Charlie’s Holdings Inc.’s October release of the 6-methyl nicotine vaporizer SPREE BAR.
Regarding its correspondence with specific companies, the FDA remains silent.
In a statement, the FDA addressed questions from Reuters regarding 6-methyl nicotine and other nicotine substitutes, saying that while further research is necessary, some preliminary findings suggest that these alternatives to nicotine may be more effective than the highly addictive drug nicotine, which can also affect the development of the adolescent brain and have long-term effects on children’s attention, learning, and memory.
Traditional nicotine is made from tobacco leaves and is present in many vapes and pouches. In contrast, 6-methyl nicotine is completely synthesised in a laboratory using chemicals.
The FDA declared that it would use all of its resources to shield children from items that could be harmful to their health and that it was using a “agency-wide perspective” when evaluating the use of such synthetic chemicals. In order to guarantee safety and effectiveness, the FDA also oversees foods, medications, cosmetics, and tobacco products.
In response to questioning from Reuters, the FDA stated, “The FDA is a data-driven agency, and we’re in the process of reviewing the available data to inform potential actions in this space.”
The news agency was informed by three university academics that there has been insufficient research done on 6-methyl nicotine to make firm judgements about its effects on health or level of addiction.
Professor Imad Damaj of Virginia Commonwealth University’s Department of Pharmacology and Toxicology stated that although his research suggested 6-methyl nicotine might be more potent than nicotine, more thorough testing was required to determine its effects on people.
The researchers noted that some of the studies in the literature were sponsored by the industry, while others were insufficient to fully comprehend the effects of 6-methyl nicotine on human bodies and concentrated on the short-term effects on animals or cells.
The 6-methyl nicotine solution used in SPREE BAR is known as “Metatine” by Charlie’s Holdings. Metatine “may have a toxicity profile similar to nicotine,” according to the SPREE BAR website.
Co-founder of Charlie’s Holdings Ryan Stump stated that the company dilutes 6-methyl nicotine in its products but recognised that further research is needed on the topic.
According to its website, SPREE BAR provides fruity flavours like ‘creamy melon’ and ‘blue razz ice’ and guarantees users 6,000 puffs from each gadget.
According to the FDA, no flavor-infused vape that uses standard nicotine has been approved for sale in the US. This is because the companies behind the products have not been able to demonstrate that the health advantages they provide to smokers exceed the known hazards to minors, who might be drawn to the flavours.
According to Stump, who spoke with Reuters, the company caters only to adults, and flavour was a key component of its goal of helping smokers give up cigarettes. According to him, Charlie’s Holdings obeys and respects the law in each market in which it conducts business.
GOING AFTER GLOBAL MARKETS
At Sultan Smoke, Anes Saleh’s vape shop in Denver, Colorado, he sells SPREE BAR. He claimed he hasn’t received any unfavourable criticism about the product and that some of his clients solely purchase Spree Bars rather than nicotine vape pens.
“The only objection I would hear against people trying this is that they are unaware of the benefits or uses of methotine,” the speaker stated.
In a statement, the American Vapour Manufacturers Association announced that the FDA has outlawed vaping devices, which were widely used by American smokers to stop smoking. As vice president of the group Allison Boughner said, that encourages the illegal market and runs the danger of encouraging people to pick up smoking again.
According to Stump, Charlie’s Holdings is developing new 6-methyl nicotine products as well as additional SPREE BAR variants. This year, SPREE BAR will be introduced globally. He refused to provide the location.
According to Samuel Benaim, the founder of Novel Compounds, the company purchases the 6-methyl nicotine solution used in SPREE BAR from another American company.
To make 6-methyl nicotine easier for producers like Charlie’s Holdings to employ in their goods, Novel Compounds imports it from abroad and modifies it. It uses the trade name imotine to market this solution.
According to tests conducted on behalf of Novel Compounds, 6-methyl nicotine is no more hazardous than regular nicotine, according to Benaim. However, he added that additional study on the chemical was required.
Benaim went on to say that Novel Compounds have legal counsel stating that the product is not categorised as a drug or tobacco product in the US. According to him, the business is dedicated to following the law.
EXTRA POTENTIAL TO NICOTINE?
According to Duke University professor Sven Jordt, who has written studies on items such as SPREE BAR, 6-methyl nicotine may be more hazardous and addictive than its conventional cousin.
He questioned, “Do we want such a chemical to be available to everyone as a recreational product?” “That raises serious doubts.”
Damaj, the Virginia Commonwealth University professor, and Jordt have never accepted money from tobacco or e-cigarette manufacturers.
Novel Compounds distributes its 6-methyl nicotine solution outside of the United States, notably in the United Kingdom, Indonesia, India, and Japan.
In the UK, Aroma King, a different business, offers 6-methyl nicotine in pouches that consumers place under their lips to experience a rush. The pouches are marketed in cans with images of gorillas decked out in suits and shades.
It claimed that compared to ordinary nicotine products, its 6-methyl nicotine products were “less toxic,” “less harmful,” and “less addictive” in a blog post published in February.
Aroma King, in a statement to Reuters, highlighted previous studies, its own toxicological and other tests, as well as the classification, labelling and packaging of substances and mixes (CLP) Regulation of the European Union, which categorises 6-methyl nicotine as less harmful.
According to Aroma King, the supplier self-classified the 6-methyl nicotine. It opted not to disclose the identity of its chemical supplier.
Zinwi Biotech, a Chinese firm that produces the liquid used in vapes, is one of four Chinese companies that own patents in China pertaining to the manufacturing of 6-methyl nicotine.
Zinwi Biotech acknowledged that it is investigating 6-methyl nicotine, but it remained silent on other issues, such as whether or not it has already sold any of the drug.
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